Transvenous Intracardiac Pacing Catheter

ABSTRACT

The embodiments described herein relate to a self-positioning, quick-deployment low profile transvenous electrode system for sequentially pacing both the atrium and ventricle of the heart in the “dual chamber” mode, and methods for deploying the same.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT application US20/52943 filed25 Sep. 2020, which claims priority benefit to U.S. provisional patentapplication 62/905,434 filed 25 Sep. 2019, the disclosure of which isincorporated herein by reference in its entirety.

BACKGROUND

The embodiments described herein relate generally to medical devicesthat provide heart pacemaking function, and more particularly to atemporary easily insertable transvenous dual-chamber sequential pacingcatheter, and systems and methods for atrio-ventricular pacing toachieve AV synchrony.

The heart requires to be paced temporarily during or after certainmedical procedures or conditions like open heart surgery, heart attack,some infections, electrolyte disturbances, cardiac trauma or otherissues. The only available temporary pacing catheters will not pace theheart in atrio-ventricular (AV) synchrony (only the right ventricle ispaced).

Establishing and maintaining atrio-ventricular (AV) synchrony in apatient is important for achieving optimal cardiovascular hemodynamics.AV synchrony is estimated to increase stroke volume by as much as 50% ina normal heart and increase cardiac index by as much as 25% to 30%.

After open heart surgery, pacing is performed using epicardial wiresthat are lightly sutured to the epicardium before the thorax is closed.Once these epicardial wires are no longer needed, these pacing wires arepulled through the skin. Pulling the pacing wires represents a risk of acardiac tamponade that can lead to death, and can also pose a risk ofinfection, myocardial damage, ventricular arrhythmias and perforation.

Existing temporary pacing catheters are also difficult to positioncorrectly and often add complications including, in the case of balloonpositioning, having the catheter move to and block the right ventricleoutflow tract and the pulmonary artery.

Existing pacing catheter leads can also move (dislodge) either whilepacing or at a critical point during a specific procedure like rapidpacing. For this reason, the mobility of the patient (ambulation) islimited when being temporary paced. Limited ambulation is known toincrease the length of stay in certain scenarios and lead to higherhealthcare costs.

Accordingly, there is a need for an AV sequential pacing catheter thatis easy to insert and position on the right chambers of the heart toreplace the current available temporary catheters/leads.

SUMMARY

The embodiments described herein are directed to an insertableatrio-ventricular sequential pacing catheter that is easy to insert andposition on the right chambers of the heart.

The present disclosure relates to an improved transvenous intracardiacpacing catheter, and particularly to devices, methods, and systems forestablishing and maintaining atrio-ventricular (AV) synchrony in apatient by providing an insertable atrio-ventricular sequential pacingcatheter system having an inner catheter, outer catheter and connectorassembly. In a preferred embodiment, the inner catheter incorporatesseven nitinol PTFE heat shrink set of wires with radiopaque tips. Fourof the wires are leads for the atrium, two are for the ventricle and oneforms the distal tip with cap. The wires are incorporated into a sevenlumen extrusion and fitted into correct position using fixtures. In apreferred embodiment, the outer catheter is a multi-durometer, coilreinforced catheter with luer hub and radiopaque tip. In a preferredembodiment, the connector assembly attached the wires to plugs forconnection to the pulse transmission unit.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of one embodiment of the device, illustratingthe atrial leads, the ventricular leads, the retractable sheath, thecombined hub and terminal connection, and steerable deploymentmechanism, and the external lead terminals, according to the invention.

FIG. 2 is a schematic view another embodiment of the device,illustrating the atrial leads, the ventricular leads, the retractablesheath, the hub, the independent terminal connection, and steerabledeployment mechanism, and the external lead terminals, according to theinvention.

FIG. 3 is a schematic of the two-inner sheath (dual lumen) embodimentillustrating the outer steerable catheter sheath housing the two innersheaths, with one inner sheath having the ventricle leads and the otherinner sheath having the atrium leads, according to the invention.

FIG. 4 is a schematic of the seven-inner sheath (multi-lumen) embodimentillustrating the outer steerable catheter sheath housing the seven innersheaths, with each inner sheath its own lead, and providing three (3)ventricle leads and four (4) atrium leads, according to the invention.

FIG. 5 is a schematic of a cross-section of the seven-inner sheath(multi-lumen) embodiment illustrating the outer steerable cathetersheath housing the seven inner sheaths, with each inner sheath its ownlead, and providing three (3) ventricle leads and four (4) atrium leads,according to the invention.

FIG. 6 is a schematic view of a cross-section of a human heart, aplurality of electrodes inserted in the ventricle and atrium contactingthe walls of the heart chambers and a pacer, according to the invention.

FIG. 7 is a chart of an acute first in human study and is useful tosupport an embodiment of the present invention. FIG. 5 shows an examplestudy of a sample of 10 patients, although not necessarily for anyspecific indication. FIG. 5 shows that procedure time can average 24minutes to position and deploy the device, pace the RV, pace the Asynchronize AV pacing, perform a left side diagnostic, and the pace theRV, pace the A, synchronize the AV pacing, and remove the device,according to the invention.

FIG. 8 is an example of a chart of data in an embodiment of theinvention from a procedure recording a non-limiting preferredembodiment. FIG. 8 shows by subject and lead, the impedance, thethreshold, and the current, recorded. This shows safe delivery with andwithout fluoroscopic guidance, successful pacing, excellent contact andhold of the leads against the cardiac tissue, with no adverse events orsignificant adverse events at discharge, according to the invention.

FIG. 9 is an illustration of one embodiment of a device being introducedinto the jugular vein of a patient, with removal of the guidewire, andintroduction of the transvenous dual-chamber sequential pacing deviceinto the steerable catheter sheath, according to the invention.

FIG. 10 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart, as shown onfluoroscopic imaging, according to the invention.

FIG. 11 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart, as shown onfluoroscopic imaging, according to the invention.

FIG. 12 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart, as shown ina cut-away view into the heart, according to the invention.

FIG. 13 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart, withventricle leads deployed from a movable inner sheath into the ventricle,according to the invention.

FIG. 14 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart, with atriumleads being deployed from a movable inner sheath into the atrium, whileventricle leads have already been deployed into the ventricle, accordingto the invention.

FIG. 15 is an illustration showing how the device can sense abnormalheart rhythm using the transvenous dual-chamber sequential pacing devicedeployed into a heart, according to the invention.

FIG. 16 is an illustration showing how the device can provide electricalstimulation to the atrium using the transvenous dual-chamber sequentialpacing device deployed into a heart, according to the invention.

FIG. 17 is an illustration showing how the device can provide electricalstimulation to the ventricle using the transvenous dual-chambersequential pacing device deployed into a heart, according to theinvention.

FIG. 18 is an illustration showing how the device can sense thecorrected normal heart rhythm using the transvenous dual-chambersequential pacing device deployed into a heart, according to theinvention.

FIG. 19 is an illustration showing how the device is removed after beingdeployed into a heart, according to the invention.

FIG. 20 is an illustration of a ventricle only embodiment of theinvention.

DETAILED DESCRIPTION

Disclosed embodiments are directed to a self-positioning,quick-deployment low profile transvenous electrode system forsequentially pacing both the atrium and ventricle of the heart in the“dual chamber” mode, comprising a plurality of insulated electricalwires bundled together to form at least two in-line sets of leads isdisclosed. The invention provides an emergency pacemaker that will paceand sense both atrial and ventricular chambers and provide “dualchamber” control of the heart using a lead that can be safely and easilyinserted into the heart in an emergency situation. “Dual chamber” pacingrefers to continuous monitoring of the spontaneous activity of the heartboth in the atria and in the ventricles, interpreting the detectedevents according certain accepted algorithms and providing stimuli tothe chambers as needed to maintain a physiologically appropriate rhythm.Importantly, the device can be deployed with and without fluoroscopicguidance. In one embodiment, a self-positioning feature allows thedevice to be used without the extensive training and specialistexperience that has been historically required for pacing devices.

In some embodiments of the invention, the device comprises three (3)ventricular leads and four (4) atrial leads, made from shape memorymaterial. Two of the three ventricular leads are bent at 90 degrees fromthe central axial lead and are 180 degrees from each other. The fouratrial leads are bent at 90 degrees from the central axis (x-axis), andare each separated 90 degrees from the adjacent leads, in the y-axisplane.

In some embodiments of the invention, both sets of leads are mounted andcontained inside a slender e.g. 8 Fr (1 mm), tubular, flexible elongatede.g. 35 cm retaining sheath that serves as a guide and delivery systemduring insertion and removal of the electrode system. Each of the wiresis surrounded individually by electrical insulation.

In some embodiments of the invention, the bundle of insulated wires canbe arranged in either a parallel or helical configuration. In order toconform to heart chambers of different sizes, the leads will be producedin different lengths and appropriate distances between the electrodes.

In some embodiments of the invention, the electrode system isconstructed by assembling a plurality of insulated superelasticelectrically conductive wires. The insulation material separates each ofthe wires from each other, but the wires are mounted in a bundle as asingle cable-like structure. At the proximal end, the electrodes areconnected to an external pacemaker At the distal end, the individualwires once inserted into the heart will make contact with either atrialor ventricular tissue. The distal ends of the individual wires mayinclude spherical electrode contacts that will make contact with atrialtissue or ventricular tissue.

In some embodiments of the invention, each of the wires has memory andis pre-formed in a specific curvature but also is resilient enough to becontained in the sheath prior to being positioned within the heartchambers. Since both sets of leads for the ventricle and the atrium arecontained inside a single slender flexible retaining sheath that is theguide and delivery system during insertion and removal of the electrodesystem, the ventricular electrode or electrodes which can be pacemakersensors or stimulators are released first after the retaining sheath hasbeen successfully inserted into the right ventricle. At this point, thesheath is retracted allowing the ventricle wire leads to escape from thesheath and because of each wire's pre-formed shape which has memory,spread out to individually contact the endocardial surfaces. The leadsexpand outwardly, engaging the tissue and chamber wall of the ventricle.If a mechanical parallel wire configuration is chosen in the sheath, thewires can be released and make contact in the same plane. Otherwise, thewires can be staggered within the ventricular chamber. If a helicalconfiguration of the wires is chosen in the sheath, the wires arestaggered upon release to cover different points of a chamber wall.Ideal wires for this configuration are disclosed in U.S. Pat. Nos.6,137,060 and 3,699,886.

Continued retraction of the sheath will then allow the escape of theatrial wires and electrodes which also have memory and which, uponescape from the sheath, will proceed outwardly towards the atrial tissuefor engagement.

As discussed above, in some embodiments of the invention, the distalends of the individual wires may have spherical conductive ball tips toprovide high current density and sensitivity. For the physician toeffectively introduce the device transvenously, the sheath will have tobe extended all the way forward initially such that it covers all thewires with the possible exception of the distal electrodes, which mayprotrude beyond the sheath during the introduction of the sheath withthe conducting leads into the heart. The path of the sheath with theleads during insertion is into the subclavian or jugular vein past theatrium and into the ventricle. Once the electrode system reaches theapex of the right ventricle, the operator begins to pull back slowly onthe sheath, thus releasing each wire individually until all necessarycontact points are made.

In some embodiments of the invention, each wire is made of asuperelastic or memory shape retention material such as Nitinol™, as thesheath is slowly pulled back the wires are released. Each wire will bepre-shaped with the proper orientation so that as the medical personnel,e.g. cardiac interventionalists, emergency medical technicians, surgicalstaff, outpatient staff, etc., pulls the sheath back, the wire fansoutwardly until the wire tips rest against the interior wall of eachchamber, thus making electrical contact. The memory in the wire willhold it in place within the chamber. The ball tip ending of each wire aswell as the highly flexible chosen material will minimize trauma to theendocardium while allowing a sufficiently large surface area forelectrical conduction.

Polymers

Any of the devices and/or components thereof may be fabricated from anysuitable biocompatible material or combination of materials. Forexample, an outer chassis, and/or components thereof may be fabricatedfrom biocompatible materials, metals, metal alloys, polymer coatedmetals, and/or the like. Suitable biocompatible materials, metals and/ormetal alloys can include polymers, co-polymers, ceramics, glasses,aluminum, aluminum alloys, stainless steel (e.g., 316 L stainlesssteel), cobalt chromium (Co—Cr) alloys, nickel-titanium alloys (e.g.,Nitinol®), and/or the like. Moreover, any of the chassis or componentsmay be covered with a suitable polymer coating, and can include naturalor synthetic rubber, polyethylene vinyl acetate (PEVA), poly-butylmethacrylate (PBMA), translute Styrene Isoprene Butadiene (SIBS)copolymer, polylactic acid, polyester, polylactide, D-lactic polylacticacid (DLPLA), polylactic-co-glycolic acid (PLGA), and/or the like.

In order for the electrode system within the sheath to freely navigatethrough the blood vessels, it must have a very smooth surface. Adequateflexibility must be achieved with materials that do not fracture or failprematurely. The insulation material used to insulate each individualwire will be of the type used in the production of existing pacingleads. Furthermore, the sheath material used will be a thermoplasticelastomer similar to those used in the manufacture of catheters and foradded strength it can be braided.

In one non-limiting embodiment, the electrode system in accordance withthis invention may be designed primarily for emergency temporary usesuch that the leads described have passive fixation. However, in anothernon-limiting example, it is possible that the present invention can beutilized as part of a permanently implanted pacemaker system such thatthe electrode would become embedded in the heart tissue or activelyattached to the endocardium by one of many means available for activefixation.

Some biocompatible synthetic material(s) can include, for example,polyesters, polyurethanes, polytetrafluoroethylene (PTFE) (e.g.,Teflon), and/or the like. Where a thin, durable synthetic material iscontemplated (e.g., for a covering), synthetic polymer materials suchexpanded PTFE or polyester may optionally be used. Other suitablematerials may optionally include elastomers, thermoplastics,polyurethanes, thermoplastic polycarbonate urethane, polyether urethane,segmented polyether urethane, silicone polyether urethane,polyetheretherketone (PEEK), silicone-polycarbonate urethane,polypropylene, polyethylene, low-density polyethylene (LDPE),high-density polyethylene (HDPE), ultra-high density polyethylene(UHDPE), polyolefins, polyethylene-glycols, polyethersulphones,polysulphones, polyvinylpyrrolidones, polyvinylchlorides, otherfluoropolymers, polyesters, polyethylene-terephthalate (PET) (e.g.,Dacron), Poly-L-lactic acids (PLLA), polyglycolic acid (PGA), poly(D,L-lactide/glycolide) copolymer (PDLA), silicone polyesters, polyamides(Nylon), PTFE, elongated PTFE, expanded PTFE, siloxane polymers and/oroligomers, and/or polylactones, and block co-polymers using the same.

Radiopaque Materials

Barium Sulfate. Barium sulfate (BaSO4) is a radiopaque material widelycompounded in medical formulations and a common filler used withmedical-grade polymers. It is an inexpensive material, costingapproximately $2/lb; and its white color can be changed with theaddition of colorants.

With a specific gravity of 4.5, barium sulfate is generally used atloadings of 20 to 40% by weight. While a 20% barium sulfate compound istypical for general-purpose medical device applications, somepractitioners prefer a higher degree of radiopacity than can be providedby that loading. With striped tubing, for example, a 40% compound isstandard.

A loading of 20% barium sulfate by weight is equivalent to about 5.8% byvolume; 40% by weight equals 14% by volume. As the barium content movesbeyond about 20% by volume, compounds begin to show losses of the basepolymer's tensile strength and other mechanical properties. It istherefore best to formulate radiopacifiers at the minimum level for eachapplication; excessive use of these fillers is not recommended.

Bismuth. Considerably more expensive than barium at $20 to $30/lb(depending on the chemical salt selected), bismuth compounds are alsotwice as dense. Bismuth trioxide (Bi2O3), which is yellow in color, hasa specific gravity of 8.9; bismuth subcarbonate (Bi2O2CO3) has aspecific gravity of 8.0; and bismuth oxychloride (BiOCl) has a specificgravity of 7.7. Because of the density, a 40% bismuth compound containsonly about half the volume ratio as a 40% barium sulfate compound. Sincebismuth produces a brighter, sharper, higher-contrast image on an x-rayfilm or fluoroscope than does barium, it is commonly used whenever ahigh level of radiopacity is required.

Compared with barium, higher loadings are also possible: even a 60%bismuth compound can maintain the same base polymer mechanicalproperties as a 40% barium sulfate compound. A 20% bismuth loading byweight equals 3% by volume; a 40% loading by weight equals 7.6% byvolume. Bismuth is sensitive to compounding and must be treated gently,with low-shear mixing recommended for optimum results. Bismuth provideshigh levels of radiopacity.

Tungsten. A fine metal powder with a specific gravity of 19.35, tungsten(W) is more than twice as dense as bismuth and can provide a highattenuation coefficient at a cost of approximately $20/lb. A loading of60% tungsten has approximately the same volume ratio as a 40% bismuthcompound. Devices can be made highly radiopaque with relatively lowloadings of tungsten, enabling good mechanical properties to bemaintained. Because of its density, tungsten is typically selected as afiller for very-thin-walled devices.

A 50% tungsten loading by weight equals only 5.4% by volume; an 80%loading by weight represents 18.5% by volume. Tungsten is black incolor, which cannot be changed with colorants. It is abrasive and cancause accelerated wear in extruders and other processing equipment.Devices filled with high loadings of tungsten will exhibit surfaceroughness. Because the material invites oxidation in the presence ofoxygen and heat and is highly flammable, care should be taken whiledrying it. With elastomers, barium sulfate mixes better than do tungstenor bismuth compounds.

Compounding Considerations

Newer x-ray machines generally operate at higher energy levels thanolder ones—typically at 80 to 125 kVp as compared with 60 to 80 kVp forolder machines. Higher energy radiation increases the transmission ofphotons and can require higher levels of radiopacity to provide thedesired attenuation. Therefore, devices produced with barium sulfatecompounds might not appear as bright on newer machines, for whichbismuth compounds would be a better choice of radiopaque filler.Blending these materials, however, can often be the best solution,especially for multipurpose formulations used over a broad range ofenergy levels. A blend of barium, easily attenuated at low energylevels, and bismuth, attenuated at higher levels, often works well.

Compounding radiopaque materials includes factoring in the degree ofattenuation of the device, the tensile strength, elongation, and othermechanical properties of the polymers. Fillers, antioxidants,stabilizers, and colorants may also be included with metallic fillers.

The present invention can be used in emergency rooms, after open heartsurgery, during or after minimally invasive heart surgery or implantprocedures such as valve repair or replacement, in intensive care units,at the bedsides, cardiac catheterization labs, ambulances, battle fieldsand other emergency settings where patients with heart block or otherlife threatening arrhythmias may be found.

Independent Claims

In a preferred embodiment, the invention provides a self-positioning,quick-deployment low profile transvenous electrode system for pacing ofa heart, comprising:

a pacemaker including a pulse generator that can provide sensing andstimuli for a ventricle or an atrium;

a plurality of insulated electrical wires bundled together to form adistal set of three (3) ventricle leads disposed within a first innersheath, and a proximal set of four (4) atrium leads disposed within asecond inner sheath, the first inner sheath and the second inner sheathdisposed within an outer steerable catheter sheath,

said outer steerable catheter sheath being movable from said first innersheath and said second inner sheath once inserted into the heart fordeploying the first inner sheath to the ventricle and the second innersheath to the atrium, said outer steerable catheter sheath beingentirely removed from the atrium and ventricle when the transvenouselectrode system is engaged,

said first inner sheath being movable to expose the distal set of three(3) ventricle leads to the ventricle, and said second inner sheath beingmovable to expose the four (4) atrium leads to the atrium,

the first inner sheath and the second inner sheath each made from apolymer, wherein the polymer is doped with a radiopaque material to forma radiopaque polymer sheath or is labelled with at least one radiopaquemarker element,

each of the ventricular and atrial leads have a proximal body portion, adistal end portion, and a tip portion,

the proximal body portion made from a radiopaque polymer-covered copperwire,

the distal end portion made from shape memory material, the shape memorymaterial selected from stainless steel, spring steel, cobalt-chromiumalloy, nickel-titanium alloy, and mixtures thereof,

the tip portion made from shape memory material and a radiopaquematerial, the radiopaque material selected from a barium-containingcompound, a bismuth-containing compound, a steel compound, atungsten-containing compound, and mixtures thereof,

two of the three ventricle leads are shape-set at a 90 degree angle inan expanded configuration, and the two ventricle leads are offset 180degrees from each other, one of the three ventricle leads is a centralaxial lead,

each of the four atrium leads are shape-set at a 90 degree angle in anexpanded configuration, and each of the four atrium leads are separated90 degrees from each other,

the steerable catheter sheath is comprised of a distal portion and aproximal portion, and has a distance marker every 10 cm along its entirelength,

the distal portion of the steerable catheter sheath is 5 cm in lengthand has a 0.010″ pitch coil and a biocompatible polymer cover,

the proximal portion of the steerable catheter sheath is 30 cm inlength, has a 0.020″ pitch coil, a biocompatible polymer cover, at aproximal end of the proximal portion has a hub element, a Touhy-Borstaccess connector with a side port, an actuator dial that allows thesteerable catheter sheath to be shaped and controlled, a deploymentstop, and a cable junction housing,

atrium lead terminals and ventricle lead terminals extend from the cablejunction housing to the pacemaker, wherein the pacemaker comprisescomputer program instructions readable by a processor to providesfunctions selected from the group consisting of: a diagnostic function,a sensor operation, a stimulation signal, a program for an individuallead for sensing, a program to reduce over-sensing of the ventricularleads by T-waves or other noise or attenuating or interfering signals, aprogram to reduce over-sensing of the atrium leads by the R-wave, aprogram to minimize cross-talk, and a program to adjust sensing andstimulation on a lead-by-lead basis;

the atrium leads shape-set to sense and stimulate an SA node area and anAV node area of the heart, the ventricle leads shape set to sense andstimulate a Bundle of His area, an Apex-Purkinje fiber area, and aFree-wall Purkinje area,

each of said ventricular leads connected to a ventricular sensor orstimulator in said pacemaker and each of said atrium leads connected toan atrium sensor or stimulator in said pacemaker.

Ventricle Only

In another preferred embodiment, the invention may provide aself-positioning, quick-deployment low profile transvenous electrodesystem for pacing of a heart, comprising:

a pacemaker including a pulse generator that can provide sensing andstimuli for a ventricle;

a pair of insulated electrical wires to form a first ventricle lead anda second ventricle lead, the first and the second ventricle leadsdisposed within an outer steerable catheter sheath,

said outer steerable catheter sheath being movable from said first andsaid second ventricle leads once inserted into the heart for deployingthe first ventricle lead and the second ventricle lead to the ventricle,said outer steerable catheter sheath being entirely removed from theventricle when the transvenous electrode system is engaged,

each of the first and the second ventricle leads have a proximal bodyportion, a distal end portion, and a tip portion,

the proximal body portion made from a radiopaque polymer-covered copperwire,

the distal end portion made from shape memory material, the shape memorymaterial selected from stainless steel, spring steel, cobalt-chromiumalloy, nickel-titanium alloy, and mixtures thereof,

the tip portion made from shape memory material and a radiopaquematerial, the radiopaque material selected from a barium-containingcompound, a bismuth-containing compound, a steel compound, atungsten-containing compound, and mixtures thereof,

the two ventricle leads are offset 180 degrees from each other,

the steerable catheter sheath is about 1.3 mm diameter or 4 French andis comprised of a distal portion and a proximal portion, and has adistance marker every 10 cm along its entire length,

the distal portion of the steerable catheter sheath is 5 cm in lengthand has a 0.010″ pitch coil and a biocompatible polymer cover,

the proximal portion of the steerable catheter sheath is 30 cm inlength, has a 0.020″ pitch coil, a biocompatible polymer cover, at aproximal end of the proximal portion has a hub element, a Touhy-Borstaccess connector with a side port, an actuator dial that allows thesteerable catheter sheath to be shaped and controlled, a deploymentstop, and a cable junction housing,

atrium lead terminals and ventricle lead terminals extend from the cablejunction housing to the pacemaker, wherein the pacemaker comprisescomputer program instructions readable by a processor to providesfunctions selected from the group consisting of: a diagnostic function,a sensor operation, a stimulation signal, a program for an individuallead for sensing, a program to reduce over-sensing of the ventricularleads by T-waves or other noise or attenuating or interfering signals, aprogram to minimize cross-talk, and a program to adjust sensing andstimulation on a lead-by-lead basis;

the ventricle leads shape set to sense and stimulate a Bundle of Hisarea and a Free-wall Purkinje area,

each of said ventricular leads connected to a ventricular sensor orstimulator in said pacemaker

Independent Sheathing

Any of the embodiments herein, including the ventricle embodiment, mayinclude wherein the (first) ventricle lead is disposed within a (first)movable inner sheath, and the (second) ventricle lead is disposed withina (second) movable inner sheath, the inner sheath each made from apolymer, wherein the polymer is doped with a radiopaque material to forma radiopaque polymer sheath or is labelled with at least one radiopaquemarker element.

Bundle Sheathing

Any of the embodiments herein may include wherein said first innersheath is a set of three independently movable inner sheaths, each ofthe three (3) ventricle leads having its own movable sheath, and whereinsaid second inner sheath is a set of four (4) independently movableinner sheaths, each of the four (4) atrium leads having its own movablesheath.

Variations

Any of the dual chamber embodiments herein may include wherein thepacemaker includes two sequential pulse generators that can providesensing and stimuli for a ventricle and an atrium for sequentiallypacing both the atrium and ventricle of a heart in the “dual chamber”mode.

Any of the embodiments of the present invention may include 4 atrial,and 3 ventricular wires in a configuration where the atrial are 90degrees from each about a Y-axis, and where the ventricular are in aplanar configuration that is perpendicular to the central X-axis.

Any of the embodiments of the present invention may include wherein theatrial leads and ventricle leads have uninsulated wire in certainlocations.

Any of the embodiments of the present invention may include wherein thecopper body portion is braided or bonded to the distal end portion,where the distal end portion is steel or NiTi alloy.

Any of the embodiments of the present invention may include wherein theshape-setting of the eyelet is performed at the same time as theshape-setting of the played portion of the leads.

Any of the embodiments of the present invention may include wherein theshape-setting is performed faster by changing the wire cross section.

Any of the embodiments of the present invention may include wherein thetip of electrode is an eyelet not ball, and wherein the tip portion is acomposite of a shape memory material and a radiopaque material.

Any of the embodiments of the present invention may include wherein theradiopaque materials are Tungsten, Barium, and/or Bismuth compounds. Inparticular, Bismuth provides a brighter luminescence under Xray. Bismuthcompounds include Bi2O3, Bi2O2CO3, and BiOCl. Barium sulfate providesexcellent compounding with polymer coatings, such as polyimides. Bariumradiopaque polymers may be used for the catheter sheath/jacket, eyelet,as an RO band, and on other electrode portions, and sheath portions.

Any of the embodiments of the present invention may include wherein thepolymer is polyimide, or where the polymer is silicone plus a lubricityagent, is made from PebaSlix 35D, is made from Pebax 72D, and the like.

Any of the embodiments of the present invention may include wherein thesheath is configured to provide a 90 degree curve over a 2.5″ diameterbend, and is also configured to provide a hockey-stick bend at a 45degree angle +/− 5 degrees.

Computer Programs

In another preferred embodiment, the invention provides wherein theinvention includes computer program instructions executable on aprocessor for performing one or more functions selected from: decreasingsensitivity of certain leads and increasing sensitivity of other leadsduring a depolarization cycle (PQRST) allows the invention to increaseSNR in the sensing function, decreasing or increasing stimulatorysignals to one or more leads allows the invention to more accuratelyprovide stimulation to the AV node, the SA node, the ventricular apex,or other cardiac tissue to provide a level of granularity to thestimulation function, programming leads so that sensing leads are notrequired to share the function of a shocking/stimulation leads, andbypassing damaged or degraded leads to allow continued functioningwithout requiring the entire device to be removed from a patient, thisincreasing the longevity of implanted devices using the inventivetechnology.

Methods

In another preferred embodiment, the invention provides acomputer-implemented method for quickly deploying a cardiac pacingdevice to a heart in a patient, comprising:

(i) Providing the transvenous, dual-chamber dual-lumen system claimedand described herein;

(ii) Accessing a jugular vein in the patient and advancing the cathetersheath under ultrasound or other non-fluoroscopic imaging modality to aright ventricle of the heart of the patient;

(iii) Withdrawing the outer steerable catheter sheath to a firstposition to expose the first inner sheath and the second inner sheath;

(iv)Withdrawing the first inner sheath to a second position to exposeand actuate the ventricle leads to connect with the ventricle tissue;

(iv)Withdrawing the second inner sheath to a third position to exposeand actuate the atrium leads to connect with atrium tissue;

(v) Using computer program instructions executable on a processor,Performing a diagnostic test to identify the patient cardiac patternsand to validate the operation of the system;

(vi) Using computer program instructions executable on a processor,Performing a cardiac pacing routine appropriate as a treatment for thepatent cardiac pattern;

(vii) Removing the catheter sheath and allowing the system to remainwithin the patient;

wherein performing steps (i)-(vii) are performed in a time period nolonger than 60 minutes.

In another preferred embodiment, the invention provides, whereinperforming steps (i)-(vii) are performed in a time period no longer than30 minutes.

In another preferred embodiment, the invention provides a transvenouselectrode system for heart block use in an emergency situation that islow cost, safe and reliable for pacing both the atrium and ventriclechambers of the heart of a patient with a heart block.

In another preferred embodiment, the invention provides an emergencyheart pacemaker that requires only a small incision to insert the leadthat will provide dual chamber (sequential) pacing and sensing for theatrial and ventricles of the heart.

In another preferred embodiment, the invention provides emergencypacemaker that will avoid problems of single chamber ventricular pacingso that the present invention provides for atrial-ventricular synchrony.

Definitions

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to limit the full scope of theclaims. Unless defined otherwise, all technical and scientific termsused herein have the same meanings as commonly understood by one ofordinary skill in the art. Nothing in this disclosure is to be construedas an admission that the embodiments described in this disclosure arenot entitled to antedate such disclosure by virtue of prior invention.

As used herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. With respect to the use of substantially any plural and/orsingular terms herein, those having skill in the art can translate fromthe plural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

In general, terms used herein, and especially in the appended claims(e.g., bodies of the appended claims) are generally intended as “open”terms (e.g., the term “including” should be interpreted as “includingbut not limited to,” the term “having” should be interpreted as “havingat least,” etc.). Similarly, the terms “comprises” and/or “comprising,”when used in this specification, specify the presence of statedfeatures, integers (or fractions thereof), steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers (or fractions thereof), steps,operations, elements, components, and/or groups thereof. As used in thisdocument, the term “comprising” means “including, but not limited to.”

As used herein the term “and/or” includes any and all combinations ofone or more of the associated listed items. It should be understood thatvirtually any disjunctive word and/or phrase presenting two or morealternative terms, whether in the description, claims, or drawings,should be understood to contemplate the possibilities of including oneof the terms, either of the terms, or both terms. For example, thephrase “A or B” will be understood to include the possibilities of “A”or “B” or “A and B.”

All ranges disclosed herein also encompass any and all possiblesubranges and combinations of subranges thereof unless expressly statedotherwise. Any listed range should be recognized as sufficientlydescribing and enabling the same range being broken down into at leastequal subparts unless expressly stated otherwise. As will be understoodby one skilled in the art, a range includes each individual member.

The embodiments herein, and/or the various features or advantageousdetails thereof, are explained more fully with reference to thenon-limiting embodiments that are illustrated in the accompanyingdrawings and detailed in the following description. Descriptions ofwell-known components and processing techniques are omitted so as to notunnecessarily obscure the embodiments herein. Like numbers refer to likeelements throughout.

The examples and/or embodiments described herein are intended merely tofacilitate an understanding of structures, functions, and/or aspects ofthe embodiments, ways in which the embodiments may be practiced, and/orto further enable those skilled in the art to practice the embodimentsherein. Similarly, methods and/or ways of using the embodimentsdescribed herein are provided by way of example only and not limitation.Specific uses described herein are not provided to the exclusion ofother uses unless the context expressly states otherwise.

Cardiac Electrophysiology

The electrical conduction system of the heart uses Nodal cells andPurkinje cells to maintain synchronization of the atria and theventricle.

The electrical current is first initiated in the SA node, the heartsnatural pacemaker, located at the top of the right atrium. The SA nodeis composed of nodal cells. In a normal resting adult heart, the SA nodeinitiates firing at 60 to 100 impulses/minute, the impulses causingelectrical stimulation and subsequent contraction of the atria. Locatedat the upper end of the septum, the sinus node creates the synchronizedneurally-mediated signal for cardiac pacing.

These signals then travel across the atrium to the atrioventricularnode, located close to the septal leaflet of the tricuspid valve. The AVnode is also made up of nodal cells and coordinates these incomingelectrical impulses.

After a slight delay so the atria can contract and complete ventricularfilling, the AV node relays the impulse to Purkinje cells in theventricle, initially conducted through the Bundle of His which extendsalong the septum, and which is then divided into the right bundle branchto conduct impulses to the right ventricle and the left bundle branch toconduct impulses to the left ventricle, causing ventricular contraction.

In a healthy heart, the signal flow from the A-V node to the free wallof the left ventricle is rapid to insure the free wall and septumcontract in synchrony. For example, a stimulating signal may flow to thefree wall in about 70-90 milli-seconds. In patients with conductionabnormalities, this timing may be significantly delayed (to 150milli-seconds or more) resulting in asynchronous contraction.

In some patients, the conduction path through the Purkinje fibers may beblocked. The location of the block may be highly localized (as in thecase of so-called “left bundle branch block” or LBBB) or may include anenlarged area of dysfunctional tissue (which can result frominfarction). In such cases, all or a portion of the free wall of theleft ventricle is flaccid while the septum is contracting. In additionto contributing to asynchronous contraction, the contraction force ofthe free wall is weakened.

To address asynchronous contraction, CHF patients can be treated withcardiac pacing of the left ventricle. Such pacing includes applying astimulus to the septal muscles in synchrony with stimulation applied tothe muscles of the free wall of the left ventricle. While infractedtissue will not respond to such stimulus, non-infarcted tissue willcontract thereby heightening the output of the left ventricle.

Figures

Referring now to FIG. 1 is a schematic view of one embodiment of thedevice, illustrating the atrial leads, the ventricular leads, theretractable sheath, the combined hub and terminal connection, andsteerable deployment mechanism, and the external lead terminals,according to the invention.

Referring now to FIG. 1, a distal central radio-opaque lead 101 is shownas one of a three-part set of ventricle leads. Ventricle leads 102 and103 are shown bent at 90 degrees away from the central axis of lead 101,and are shown in a 180 degrees opposition position from each other lead102 is 180 degrees opposite lead 103 in the y-axial plane.

In a preferred embodiment, ventricle leads are formed from 0.010″Nitinol. Lead 101 extends axially 6 cm from a distal radio-opaque band.Leads 102 and 103 bend away from the central lead and extend 4 cm away,each, from the central axis, respectively.

Atrium leads 104, 105, 106, 107 are bent 90 degrees extending away fromthe central axis, and are also bent 90 degrees from each other in they-axis plane. Atrium leads extend 4 cm away, each, from the centralaxis, respectively.

Steerable catheter sheath is comprised of a distal portion 109 that is 5cm in length and has a 0.010″ pitch coil. In a preferred embodiment, thedistal portion is made from PebaSlix 35 D. Steerable catheter sheath isalso comprised of a proximal portion 113 that is 30 cm in length and hasa 0.020″ pitch coil. In a preferred embodiment, the proximal portion ismade from Pebax 72D. The sheath is configured to provide a 90 degreecurve over a 2.5″ diameter bend, and is also configured to provide ahockey-stick bend at a 45 degree angle +/− 5 degrees. Sheath has OSmarkers 110, 111, 112 located every 10 cm along its length from thedistal tip 108.

At a proximal end, sheath has a glued hub 114, a Touhy-Borst accessconnector with a side port 115. Actuator dial 116 is located at theproximal end of the sheath and allows the sheath to be shaped andcontrolled. Red deployment stop 117 connects the last 20 cm 118 of thesheath to the cable junction housing 119.

Programmable Leads

Atrium lead terminals 120, 121 and ventricle lead terminals 122, 123allow the device to be connected to and operated from an external unitsuch as a ICD, pacer, diagnostic, or other unit that can provide sensoroperation, stimulation signal, programming for individual leads toimprove sensing, avoid over-sensing of the ventricular lead by T-wavesor other noise or attenuating or interfering signals, avoid over-sensingof the atrium leads by the R-wave, avoid cross-talk, or customizesensing and stimulation on a lead-by-lead basis.

Also contemplated as within the scope of the invention is the usedigital signal processing in conjunction with the use of multiple leads.Multiple input, multiple output (MIMO), single input multiple output(SIMO), single input single output (SISO), and multiple input singleoutput (MISO) can be programmed in the control unit to take advantage ofthe multiple lead architecture. For example, decreasing sensitivity ofcertain leads and increasing sensitivity of other leads during adepolarization cycle (PQRST) allows the invention to increase SNR in thesensing function. Similarly, decreasing or increasing stimulatorysignals to one or more leads allows the invention to more accuratelyprovide stimulation to the AV node, the SA node, the ventricular apex,or other cardiac tissue to provide a level of granularity to thestimulation function not previously available to practitioners.Likewise, unlike previous devices, the availability of multiple,programmable leads means that sensing leads are not required to sharethe function of a shocking/stimulation leads. Further, damaged ordegraded leads can be bypassed allowing continued functioning withoutrequiring the entire device to be removed from a patient, thisincreasing the longevity of implanted devices using the inventivetechnology.

As is customary with implantable pulse generators, the device may beprogrammable to achieve either conventional bipolar or unipolarstimulation or to achieve the stimulation of the present inventionthrough an external programmer or controlled automatically by thedevice. The selection can be based on user preference or be driven byphysiological factors such as widths of the patient's QRS complex or theconduction interval between the stimulus to a far away region in theheart. In addition switching between the pacing of the present inventionand conventional pacing can also be determined by the percentage ofpacing with a preference for a higher percentage with the pacing of thepresent invention. Further, the switching from the conventional pacingto the present invention pacing can be used when there exists an exitblock or the pacing electrode is located in infracted myocardium whenconventional pacing can not effect the depolarization of the myocardiumat the high output level. The automatic determination can be effectedthrough the deployment of any automatic capture detection technologythat exists in the prior art. Additionally, wireless network enabledswitching function for therapy optimization can also be implemented withthe present invention. In such case, certain patient physiologic dataare gathered by the implantable device and sent to a remoteserver/monitor through a wireless communication network.

The present invention can also be extended to the defibrillation therapywhere high-energy pulses with various waveforms are delivered throughelectrode systems to treat tachycardia and fibrillation (both atrium andventricle). The present invention is believed to be able to achievelower defibrillation threshold due to better distribution of theelectrical field, causing higher voltage gradient at least in certainparts of the heart compared to that by the conventional defibrillationconfiguration. Additionally, the present invention can be used toperform anti-tachy pacing where faster than conventional pacing pulsesequences are used to stop certain tachyarrhythmia. The presentinvention is believed to be advantageous due to the wider coverage ofthe electrical field and the capability of capturing special conductionssystem in the heart (both atrium and ventricle).

FIG. 2 is a schematic view another embodiment of the device,illustrating the atrial leads 104, 105, 106, 107, the ventricular leads101, 102, 103, the retractable sheath 109, 113, the hub 114, theindependent terminal connection 119, and steerable deployment mechanism116, and the external lead terminals 120, 121, 122, 123, according tothe invention. FIG. 2 also shows a 20 cm segment 118 from the deploymentstop 117 and the terminal connection 119.

FIG. 3 is a schematic of the two-inner sheath embodiment illustratingthe outer steerable catheter sheath 301 housing the two inner sheaths302, 303, with one inner sheath 303 having the ventricle leads and theother inner sheath 302 having the atrium leads, according to theinvention. Eyelet tip 305 is constructed with radiopaque material andconfigured/shaped, e.g. as a loop, to have a surface area larger thanthe point cross-section of a wire lead. In a preferred embodiment, theeyelet tip is 0.2-1.0 mm in area. Copper wire body portion 306 of thewire lead runs the length of the catheter from the pacemaker up to thedistal shape memory portion 307. Shape memory portion 307 is attached tothe copper wire 306 by bond, braid, weld, etc.

FIG. 4 is a schematic of the seven-inner sheath (multi-lumen) embodimentillustrating the outer steerable catheter sheath 401 housing the seveninner sheaths, with each inner sheath 404 having its own lead, andproviding three (3) ventricle leads 403 and four (4) atrium leads 402,according to the invention. Eyelet tip 405 is constructed withradiopaque material and configured/shaped, e.g. as a loop, to have asurface area larger than the point cross-section of a wire lead. In apreferred embodiment, the eyelet tip is 0.2-1.0 mm in area. Copper wirebody portion 406 of the wire lead runs the length of the catheter fromthe pacemaker up to the distal shape memory portion 407. Shape memoryportion 407 is attached to the copper wire 406 by bond, braid, weld,etc.

FIG. 5 is a schematic of a cross-section of the seven-inner sheath(multi-lumen) embodiment 501 illustrating the outer steerable cathetersheath 501 housing the seven inner sheaths 502, 503, with each innersheath its own lead, and providing three (3) ventricle leads and four(4) atrium leads, according to the invention.

Referring now to the FIG. 6, an external pacemaker 14 is shown connectedto a bundle of insulated wire electrical conductors wrapped in a sheath12. Specifically, the pacemaker 14 as shown is connected to a bundle ofseven insulated conductive wires, three wires 20, 22, 26 of which aredisposed within the ventricle and four wires 30, 32, 34, 36 of which aredisposed in the atrium 28. The wires are bundled in a sheath 12 that wasinserted into the ventricle and then pulled backward, exposing the threeventricle leads which are now contacting the walls of the ventricle dueto the retained curved memory of each wire. As the sheath 12 is furtherwithdrawn into the atrium, four additional electrodes 30, 32, 34, 36 areshown contacting atrial chamber 28 walls in accordance with the presentinvention.

As shown in the drawing, the invention as disclosed is a low profiletransvenous electrode system for sequentially pacing both the atrium andventricle of the heart in a dual chamber mode. As shown in the drawing,there are a plurality of insulated electrical wires represented that areelectrical conductors and that are wrapped in electrical insulators. Thewires are bundled together into two separate in-line sets of leads. Eachwire has memory and is resilient. During manufacturing, each wire ispre-formed in a particular curvature and length so that when disposedwithin a heart chamber, atrium or ventricle, the electrode end of thewire will engage the chamber wall for electrical pulse transfer. In apreferred embodiment, the device comprises three (3) ventricular leadsand four (4) atrial leads, made from shape memory material. Two of thethree ventricular leads are bent at 90 degrees from the central axiallead and are 180 degrees from each other. The four atrial leads are bentat 90 degrees from the central axis (x-axis), and are each separated 90degrees from the adjacent leads, in the y-axis plane.

Both sets of leads may also be mounted and contained inside a slendere.g. 8 Fr (8/3=2.66 mm), tubular, flexible elongated e.g. 35 cmretaining sheath that serves as a guide and delivery system duringinsertion and removal of the electrode system.

Each of the wires in the ventricle could be of different lengths withdifferent shapes so that when the sheath is removed, each wire expandsout by memory to have sufficient resiliency in distance to contact theinner wall of the ventricle as shown with the electrode points flushagainst the ventricle wall. There is a certain amount of resiliency ineach wire holding the wire against the wall during pacing in theposition as shown. The four wires used in the atrium are also pre-formedin curvature and length so that when the sheath is removed, wires expandresiliently against the walls of the atrium as shown in the drawing withelectrode points disposed at the end of each wire against the walltissue. The resiliency in each wire will hold the electrodes against thewall of the atrium while pacing.

The external pacemaker 14 provides the electrical pulses for thesequential pacing. The pacemaker 14 has two sequential pulse generators16 and 18 which are connected to the proximal ends of the wires forproviding the sequential pulses to both the ventricle through wires andto the atrium through wires. The external pacemaker itself isconventional in operation.

Pulse Generator

The term “pulse generator” is intended to include pacemakers, converterdefibrillators and cardia resynchronization therapies (CRT), all knownin the art.

It will be appreciated that the prior art contains numerous examples ofcardiac leads for placement in a chamber of the heart, electrodes,attachment mechanisms, conductors and/or connector pins.

The pulse generator contains internal circuitry for creating electricalimpulses which are applied to the electrodes after the lead is connectedto the pulse generator. Also, such circuitry may include sensing andamplification circuitry so that electrodes may be used as sensingelectrodes to sense and report on the patient's electrophysiology.

The lead may be introduced to the vasculature through a small incisionand advanced through the vasculature and into the right atrium RA andright ventricle to the position. Such advancement typically occurs in anelectrophysiology lab where the advancement of the lead can bevisualized through fluoroscopy.

The pulse generator may contain a battery as a power supply.

The pulse generator circuitry controls the parameters of the signalscoupled to the electrodes. These parameters can include pulse amplitude,timing, pulse duration by way of example. The internal circuitry furtherincludes circuit logic permitting reprogramming of the pulse generatorto permit a physician to alter pacing parameters to suit the need of aparticular patient. Such programming can be affected by inputtingprogramming instructions to the pulse generator via wirelesstransmission from an external programmer Most commonly, the electrode isconnected by the circuitry to an electrical ground.

In a preferred embodiment, the pulse generator may be external andcoupled to the electrodes by percutaneous leads or wirelesstransmission.

Electrode Leads

The leads which are the wire conductors and electrodes are manufacturedin different lengths and curved resiliently as discussed above withapproximate distances between the electrodes to create a configurationor pattern as shown.

In a preferred embodiment, the leads are established inside theventricle and established in the atrium.

The wires may have memory and with their pre-formed curvatures areresilient enough to be bundled in a small sheath prior to being mountedwithin the heart chambers. Both sets of wires may be contained inside asingle, cylindrical, flexible retaining sheath that is the guide anddelivery system during insertion and removal of the electrode system.

The ventricular electrodes may be pacemaker sensors or stimulators arereleased first after the retaining sheath has been successfully insertedinto the right ventricle. The sheath may be retracted allowing theelectrodes and wires to spread out and contact the endocardial surfaces.The wires expand outwardly as the sheath is removed engaging the tissueand chamber wall of the ventricle.

With a parallel configuration of wires is chosen, the wires can bereleased and make contact on the same plane within the ventricularchamber or they can be staggered.

The continued retraction of sheath may allow the escape of the atrialwires from the sheath which proceed toward the atrial tissue forengagement of the electrodes against the atrial wall.

Once the electrodes are disposed within the ventricular chamber and theatrium, sequential pacing can be initiated in the atrium and ventriclein a dual chamber mode providing an emergency pacemaker that will paceand sense both atrial and ventricular chambers and provide dual chambercontrol of the heart.

The dual chamber pacing refers to continuous monitoring of thespontaneous activity of the heart both in the atrial and in theventricles interpreting the detective events according to certainaccepted algorithms and providing stimuli to the chambers as needed tomaintain a physiologically appropriate rhythm.

FIG. 7 is a chart of an acute first in human study and is useful tosupport an embodiment of the present invention. FIG. 7 shows an examplestudy of a sample of 10 patients, although not necessarily for anyspecific indication. FIG. 7 shows that procedure time can average 24minutes to position and deploy the device, pace the RV, pace the Asynchronize AV pacing, perform a left side diagnostic, and the pace theRV, pace the A, synchronize the AV pacing, and remove the device.

FIG. 8 is an example of a chart of data in an embodiment of theinvention from a procedure recording a non-limiting preferredembodiment. FIG. 8 shows by subject and lead, the impedance, thethreshold, and the current, recorded. This shows safe delivery with andwithout fluoroscopic guidance, successful pacing, excellent contact andhold of the leads against the cardiac tissue, with no adverse events orsignificant adverse events at discharge.

FIGS. 9A, 9B, 9C is a sequence illustration of one embodiment. FIG. 9Ashows a device being introduced into the jugular vein of a patient usinga guidewire 901 and introducer 902. Luer 903 is shown connecting nearhub 904, with outer delivery catheter 905 accessing down the jugularvein. FIG. 9B shows removal of the guidewire 901. FIG. 9C showsintroduction of the transvenous dual-chamber sequential pacing devicehaving steerable catheter sheath 906 into the deliver catheter 905.

FIG. 10 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart usingsteerable catheter 906, as shown on fluoroscopic imaging.

FIG. 11 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart usingsteerable catheter 906, as shown on fluoroscopic imaging.

FIG. 12 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart using asteerable catheter 906, as shown in a cut-away view into the heart.

FIG. 13 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart, withventricle leads 907, 908, 909 deployed from a movable inner sheath intothe ventricle.

FIG. 14 is an illustration of one embodiment of the transvenousdual-chamber sequential pacing device deployed into a heart, with atriumleads 910, 911, 912, 913 being deployed from a movable inner sheath intothe atrium, while ventricle leads have already been deployed into theventricle.

FIG. 15 is an illustration showing how the device can sense abnormalheart rhythm using the transvenous dual-chamber sequential pacing devicedeployed into a heart.

FIG. 16 is an illustration showing how the device can provide electricalstimulation to the atrium using the transvenous dual-chamber sequentialpacing device deployed into a heart.

FIG. 17 is an illustration showing how the device can provide electricalstimulation to the ventricle using the transvenous dual-chambersequential pacing device deployed into a heart.

FIG. 18 is an illustration showing how the device can sense thecorrected normal heart rhythm using the transvenous dual-chambersequential pacing device deployed into a heart.

FIG. 19 is an illustration showing how the device is removed after beingdeployed into a heart. Here, the leads may be removed by simply pulling,in one embodiment. In another embodiment, the sheath(s) may bere-introduced to gather the leads prior to removal.

FIG. 20 is an illustration of a ventricle only embodiment of theinvention. FIG. 20 shows catheter 2001 having the unipolar leads 2002,2003 disposed therein. The leads 2002, 2003 are shown having optionalradiopaque insulating covering 2004 in a non-limiting embodiment.Conventional temporary pacemaker 2005 is attached to the leads by way ofthe brachial vein to provide dual ventricular leads in the rightventricle for pacing. In a non-limiting preferred embodiment, thecatheter if 4 French in size, or 4/3 mm (1.33 mm) in diameter. Leads2002, 2003 may include radiopaque eyelet tips, and may also include aproximal portion made of copper with a distal portion made from steel ornickel-titanium (NiTi) alloy, in a non-limiting embodiment as previouslydescribed.

Legal Equivalents

Many modifications and variations can be made without departing from itsspirit and scope, as will be apparent to those skilled in the art.Functionally equivalent methods and apparatuses within the scope of thedisclosure, in addition to those enumerated herein, will be apparent tothose skilled in the art from the foregoing descriptions. Suchmodifications and variations are intended to fall within the scope ofthe appended claims. The present disclosure is to be limited only by theterms of the appended claims, along with the full scope of equivalentsto which such claims are entitled. It is to be understood that thisdisclosure is not limited to particular methods, reagents, compounds,compositions or biological systems, which can, of course, vary. It isalso to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto be limiting.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods described above indicate certain eventsoccurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

Where schematics and/or embodiments described above indicate certaincomponents arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. Any portion of theapparatus and/or methods described herein may be combined in anycombination, except mutually exclusive combinations.

The embodiments described herein can include various combinations and/orsub-combinations of the functions, components, and/or features of thedifferent embodiments described. Various of the above-disclosed andother features and functions, or alternatives thereof, may be combinedinto many other different systems or applications. Various presentlyunforeseen or unanticipated alternatives, modifications, variations, orimprovements therein may be subsequently made by those skilled in theart, each of which is also intended to be encompassed by the disclosedembodiments.

1. A self-positioning, quick-deployment low profile transvenouselectrode system for pacing of a heart, comprising: a plurality ofinsulated electrical wires bundled together to form a distal set ofthree (3) ventricle leads disposed within a first inner sheath, and aproximal set of four (4) atrium leads disposed within a second innersheath, the first inner sheath and the second inner sheath disposedwithin an outer steerable catheter sheath, said outer steerable cathetersheath being movable from said first inner sheath and said second innersheath once inserted into the heart for deploying the first inner sheathto the ventricle and the second inner sheath to the atrium, said outersteerable catheter sheath being entirely removed from the atrium andventricle when the transvenous electrode system is engaged, said firstinner sheath being movable to expose the distal set of three (3)ventricle leads to the ventricle, and said second inner sheath beingmovable to expose the four (4) atrium leads to the atrium, the firstinner sheath and the second inner sheath each made from a polymer,wherein the polymer is doped with a radiopaque material to form aradiopaque polymer sheath or is labelled with at least one radiopaquemarker element, each of the ventricular and atrial leads have a proximalbody portion, a distal end portion, and a tip portion, the proximal bodyportion made from a radiopaque polymer-covered copper wire, the distalend portion made from shape memory material, the shape memory materialselected from stainless steel, spring steel, cobalt-chromium alloy,nickel-titanium alloy, and mixtures thereof, the tip portion made fromshape memory material and a radiopaque material, the radiopaque materialselected from a barium-containing compound, a bismuth-containingcompound, a steel compound, a tungsten-containing compound, and mixturesthereof, two of the three ventricle leads are shape-set at a 90 degreeangle in an expanded configuration, and the two ventricle leads areoffset 180 degrees from each other, one of the three ventricle leads isa central axial lead, each of the four atrium leads are shape-set at a90 degree angle in an expanded configuration, and each of the fouratrium leads are separated 90 degrees from each other, the steerablecatheter sheath is comprised of a distal portion and a proximal portion,and has a distance marker every 10 cm along its entire length, thedistal portion of the steerable catheter sheath is 5 cm in length andhas a 0.010″ pitch coil and a biocompatible polymer cover, the proximalportion of the steerable catheter sheath is 30 cm in length, has a0.020″ pitch coil, a biocompatible polymer cover, at a proximal end ofthe proximal portion has a hub element, a Touhy-Borst access connectorwith a side port, an actuator dial that allows the steerable cathetersheath to be shaped and controlled, a deployment stop, and a cablejunction housing, atrium lead terminals and ventricle lead terminalsextend from the cable junction housing and are adapted to be connectedto a pacemaker; the atrium leads configured using heating of the shapememory material to a shape adapted to connect to an SA node area and anAV node area of the heart, the ventricle leads configured using heatingof the shape memory material to a shape adapted to connect to a Bundleof His area, an Apex-Purkinje fiber area, and a Free-wall Purkinje area,2. The system of claim 1, wherein the pacemaker comprises computerprogram instructions saved to a memory and readable by a processor toprovides functions selected from the group consisting of: a diagnosticfunction, a sensor operation, a stimulation signal, a program for anindividual lead for sensing, a program to reduce over-sensing of theventricular leads by T-waves or other noise or attenuating orinterfering signals, a program to reduce over-sensing of the atriumleads by the R-wave, a program to minimize cross-talk, and a program toadjust sensing and stimulation on a lead-by-lead basis wherein thepacemaker includes a sequential pulse generator adapted to be disposedwithin an atrium of a heart and a second sequential pulse generatoradapted to be disposed within a ventricle of the heart for sequentiallypacing both the atrium and ventricle of a heart.
 3. The system of claim2 wherein the pacemaker includes computer program instructions saved tothe memory and executable by the processor for performing digital signalprocessing for the ventricle leads and the atrium leads, wherein thedigital signal processing is selected from the group consisting of:multiple input, multiple output (MIMO), single input multiple output(SIMO), single input single output (SISO), and multiple input singleoutput (MISO).
 4. The system of claim 3, wherein the computer programinstructions saved to the memory and executable by the processorprovides one or more functions selected from: decreasing sensitivity ofcertain leads and increasing sensitivity of other leads during adepolarization cycle (PQRST) to increase SNR in the sensing function,decreasing or increasing stimulatory signals to one or more leads tomore accurately provide stimulation to the AV node, the SA node, theventricular apex, or other cardiac tissue to provide a level ofgranularity to the stimulation function, programming leads to bifurcatethe sensing leads from the shocking/stimulation leads, and bypassing adamaged or degraded lead to allow continued functioning withoutrequiring the entire device to be removed from a patient.
 5. The systemof claim 1, wherein said first inner sheath is a set of threeindependently movable inner sheaths, each of the three (3) ventricleleads having its own movable sheath, and wherein said second innersheath is a set of four (4) independently movable inner sheaths, each ofthe four (4) atrium leads having its own movable sheath.
 6. A method ofusing the system of claim 2, comprising: (i) Accessing a jugular vein inthe patient and advancing the outer steerable catheter sheath underultrasound or other non-fluoroscopic imaging modality to a rightventricle of a heart of a patient; (ii) Withdrawing the outer steerablecatheter sheath to a first position to expose the first inner sheath andthe second inner sheath; (iii) Withdrawing the first inner sheath to asecond position to expose and actuate the ventricle leads to connectwith the ventricle tissue; (iv) Withdrawing the second inner sheath to athird position to expose and actuate the atrium leads to connect withatrium tissue; (v) Performing a diagnostic test to identify the patientcardiac patterns and to validate the operation of the system; (vi)Performing a cardiac pacing routine appropriate as a treatment for thepatent cardiac pattern; (vii) Removing the catheter sheath and allowingthe system to remain within the patient.
 7. The method of claim 6,wherein performing steps (i)-(iv) are performed in a time period nolonger than 60 minutes.
 8. The method of claim 6, wherein performingsteps (i)-(iv) are performed in a time period no longer than 30 minutes.9. A self-positioning, quick-deployment low profile transvenouselectrode system for pacing of a heart, comprising: a pair of insulatedelectrical wires to form a first ventricle lead and a second ventriclelead, the first and the second ventricle leads disposed within an outersteerable catheter sheath, said outer steerable catheter sheath beingmovable from said first and said second ventricle leads once insertedinto the heart for deploying the first ventricle lead and the secondventricle lead to the ventricle, said outer steerable catheter sheathbeing entirely removed from the ventricle when the transvenous electrodesystem is engaged, each of the first and the second ventricle leads havea proximal body portion, a distal end portion, and a tip portion, theproximal body portion made from a radiopaque polymer-covered copperwire, the distal end portion made from shape memory material, the shapememory material selected from stainless steel, spring steel,cobalt-chromium alloy, nickel-titanium alloy, and mixtures thereof, thetip portion made from shape memory material and a radiopaque material,the radiopaque material selected from a barium-containing compound, abismuth-containing compound, a steel compound, a tungsten-containingcompound, and mixtures thereof, the two ventricle leads are offset 180degrees from each other, the steerable catheter sheath is about 1.3 mmdiameter or 4 French and is comprised of a distal portion and a proximalportion, and has a distance marker every 10 cm along its entire length,the distal portion of the steerable catheter sheath is 5 cm in lengthand has a 0.010″ pitch coil and a biocompatible polymer cover, theproximal portion of the steerable catheter sheath is 30 cm in length,has a 0.020″ pitch coil, a biocompatible polymer cover, at a proximalend of the proximal portion has a hub element, a Touhy-Borst accessconnector with a side port, an actuator dial that allows the steerablecatheter sheath to be shaped and controlled, a deployment stop, and acable junction housing, atrium lead terminals and ventricle leadterminals extend from the cable junction housing; the ventricle leadsconfigured using heating of the shape memory material to a shape adaptedto connect to a Bundle of His area and a Free-wall Purkinje area
 10. Thesystem of claim 9, wherein the first ventricle lead is disposed within afirst movable inner sheath, and the second ventricle lead is disposedwithin a second movable inner sheath, the first inner sheath and thesecond inner sheath each made from a polymer, wherein the polymer isdoped with a radiopaque material to form a radiopaque polymer sheath oris labelled with at least one radiopaque marker element.